1. Field of the Invention
This invention relates to a multiple-use, implantable, intraosseous device and a method for implanting, using and removing such a device.
2. Background of the Invention
It has long been recognized that access to the vascular system is available via bone marrow sinuses. See, e.g., Tocantins, O'Neill, and Jones, Infusion of Blood and Other Fluids Via the Bone Marrow, Journal of the American Medical Association, Vol. 117, pp. 1129-34 (1941); Turkel and Bethell, A New and Simple Instrument for Administration of Fluids Through Bone Marrow, War Medicine, pp. 222-25 (1944). Infusion of drugs or other fluids into the marrow (intraosseous infusion) results in rapid transmission of such fluids into the vascular system. This method of infusion can be quite important when the patient has very low blood pressure or collapsed veins. Several intraosseous infusion devices have been developed.
Development of intraosseous devices has proceeded along two distinct lines. The first line involved the development of intraosseous infusion devices as an alternative to traditional intravenous infusion systems in situations requiring multiple infusions. These multiple infusion devices consist typically of a threaded needle or cannula which is screwed manually into the bone. Many multiple infusion devices include a cutting blade which bores a hole into the bone as the device is being rotated, thereby cutting a hole in the bone and threading the intraosseous device through that hole in a single step. Pshenichny et al. (U.S. Pat. No. 3,750,667) and Hofsess (U.S. Pat. No. 3,893,445) are illustrative of such devices. Other devices from this line of development for long-term vascular access require boring a small hole into the bone, and then screwing the device into the bone through this hole. Von Hoff et al. (U.S. Pat. No. 4,772,261) illustrates this approach. Miller et al. (U.S. Pat. No. 5,122,114) discloses a device that can be installed using either the pre-boring method or the bore-as-threaded method. Both the Von Hoff device and the implanted version of the Miller device are surgically installed. Such procedures are performed typically by surgeons or other physicians in operating rooms or special procedure rooms. The Miller device can be percutaneously installed, thereby avoiding the need for surgery, but that device still requires a skilled medical professional for proper insertion.
Some multiple infusion intraosseous devices allow for non-surgical installation. An example from this line is the SUR-FAST Intraosseous Infusion Needle Set (C-T-DINH 593) marketed by Cook Critical Care. The SUR-FAST device is a hand-held intraosseous needle with a bone cutting blade at its tip. To install this device, a small incision in the soft tissue is made at the implantation site, and the device is then threaded directly through the outer surface of the bone. While the SUR-FAST device can be installed more easily and quickly than some other intraosseous infusion systems, it still requires that an incision, to the bone, be made at the implantation site and that the device be manually screwed into the bone. In addition, the SUR-FAST device relies on the medical professional's dexterity to ensure proper alignment. Cook Critical Care also markets disposable intraosseous needle which is unthreaded and is implanted without an incision. This needle (C-T-DIN 593) must be manually rotated by the operator so that its cutting tip will penetrate the surface of the bone. As with the SUR-FAST device, alignment depends upon the expertise and dexterity of the operator. Several other manually inserted intraosseous needles have been developed, including the Jamshidi Illinois bone marrow needle and the device described in U.S. Pat. No. 4,969,870.
Recently, a second type of intraosseous infusion device has been developed. This device is not manually screwed or rotated into the bone, but uses momentum to rapidly and directly puncture the exterior surface of the bone with an intraosseous needle and automatically injects a small drug bolus. This injection method is faster and easier to use than the earlier screw-in type devices. Kramer et al. (U.S. Pat. No. 5,176,643) demonstrates this type of device. Such a device allows for emergency application of a life-saving drug through intraosseous infusion, but does not allow for multiple infusions or large volume infusions.
Although the existing intraosseous infusion devices offer significant benefits over other systems, namely intravenous infusion systems, none of these devices allow for rapid, easy and reliable administration of multiple doses of drugs or large volume infusions in an emergency situation. The only existing multiple-use emergency intraosseous infusion devices require an experienced and well-trained technician, take many seconds to minutes to implant, and provide no reliable method for ensuring proper alignment or installation of the device.
Existing intraosseous devices designed for multiple infusions employ a single lumen design, which limits the devices to sequential operations. There is a need for an intraosseous infusion and sampling device which can accommodate simultaneous operations, whether such operations be the simultaneous administration of different fluids or simultaneous infusion and monitoring. A multiple lumen device is needed to provide these capabilities.
There is a further need for an emergency system for monitoring blood chemistry. None of the intraosseous infusion devices previously discussed offer this capability. Connecting an intraosseous blood chemistry sensor to a "smart" control unit may provide valuable information and guidance to emergency medical personnel and might allow microprocessor controlled automated delivery of therapy.